Study Summary
This trial is comparing two different ways to fix a burst brain aneurysm in people not previously included in a study.
Eligible Conditions
- Ruptured Aneurysm
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: one year and five years
12 months
poor clinical outcome(mRS>2)
Month 12
Occurence of a "major" (saccular) aneurysm recurrence
Within a few hours (while awaiting treatment)
Occurence of aneurysm re-rupture following randomization but before treatment initiation
one year
Occurrence of an intracranial hemorrhage following treatment
one year and five years
Overall mortality and morbidity
Hour 48
Failure of aneurysm occlusion using the intended treatment modality
within a month or at discharge if earlier
Peri-treatment hospitalization lasting more than 20 days and/or discharge to a location other than home
Trial Safety
Trial Design
2 Treatment Groups
Endovascular management
1 of 2
Surgical management
1 of 2
Active Control
1724 Total Participants · 2 Treatment Groups
Primary Treatment: Endovascular management · No Placebo Group · N/A
Endovascular management
Procedure
ActiveComparator Group · 1 Intervention: Endovascular management · Intervention Types: ProcedureSurgical management
Procedure
ActiveComparator Group · 1 Intervention: surgical management · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one year and five years
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
329 Previous Clinical Trials
112,598 Total Patients Enrolled
14 Trials studying Aneurysm
4,342 Patients Enrolled for Aneurysm
Max Findlay, MDPrincipal InvestigatorUniversity of Alberta
Jean Raymond, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
9 Previous Clinical Trials
3,007 Total Patients Enrolled
6 Trials studying Aneurysm
1,525 Patients Enrolled for Aneurysm
Tim Darsaut, MDPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
2,291 Total Patients Enrolled
2 Trials studying Aneurysm
2,291 Patients Enrolled for Aneurysm
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have a certain level of severity of subarachnoid hemorrhage, which is grade 4 or less.
References
- Raymond, J., M. Kotowski, T.E. Darsaut, A.J. Molyneux, and R.S. Kerr. 2012. “Ruptured Aneurysms and the International Subarachnoid Aneurysm Trial (ISAT): What Is Known and What Remains to Be Questioned”. Neurochirurgie. Elsevier BV. doi:10.1016/j.neuchi.2012.02.020.
- Molyneux, Andrew. 2002. “International Subarachnoid Aneurysm Trial (ISAT) of Neurosurgical Clipping Versus Endovascular Coiling in 2143 Patients with Ruptured Intracranial Aneurysms: A Randomised Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(02)11314-6.
- Gnanalingham, Kanna K., Vasilis Apostolopoulos, Sinan Barazi, and Kevin O’Neill. 2006. “The Impact of the International Subarachnoid Aneurysm Trial (ISAT) on the Management of Aneurysmal Subarachnoid Haemorrhage in a Neurosurgical Unit in the UK”. Clinical Neurology and Neurosurgery. Elsevier BV. doi:10.1016/j.clineuro.2005.11.001.
- McDougall, Cameron G., Robert F. Spetzler, Joseph M. Zabramski, Shahram Partovi, Nancy K. Hills, Peter Nakaji, and Felipe C. Albuquerque. 2012. “The Barrow Ruptured Aneurysm Trial”. Journal of Neurosurgery. Journal of Neurosurgery Publishing Group (JNSPG). doi:10.3171/2011.8.jns101767.
- Darsaut, Tim E, Andrew S Jack, Richard S Kerr, and Jean Raymond. 2013. “International Subarachnoid Aneurysm Trial – ISAT Part II: Study Protocol for a Randomized Controlled Trial”. Trials. Springer Science and Business Media LLC. doi:10.1186/1745-6215-14-156.
- Molyneux, Andrew. 2002. “International Subarachnoid Aneurysm Trial (ISAT) of Neurosurgical Clipping Versus Endovascular Coiling in 2143 Patients with Ruptured Intracranial Aneurysms: A Randomised Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(02)11314-6.
- Gnanalingham KK, Apostolopoulos V, Barazi S, O'Neill K. The impact of the international subarachnoid aneurysm trial (ISAT) on the management of aneurysmal subarachnoid haemorrhage in a neurosurgical unit in the UK. Clin Neurol Neurosurg. 2006 Feb;108(2):117-23. doi: 10.1016/j.clineuro.2005.11.001. Epub 2005 Dec 20.
- Molyneux A, Kerr R, Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomised trial. Lancet. 2002 Oct 26;360(9342):1267-74. doi: 10.1016/s0140-6736(02)11314-6.
- Raymond J, Kotowski M, Darsaut TE, Molyneux AJ, Kerr RS. Ruptured aneurysms and the International Subarachnoid Aneurysm Trial (ISAT): What is known and what remains to be questioned. Neurochirurgie. 2012 Apr-Jun;58(2-3):103-14. doi: 10.1016/j.neuchi.2012.02.020. Epub 2012 Apr 4. English, French.
- 2012. "International Subarachnoid Aneurysm Trial II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01668563.
Frequently Asked Questions
What is the size of this clinical research cohort?
"1724 qualified participants are necessary for this medical trial to be a success. Participants can join at numerous locations, including Montefiore Medical Center in Bronx, New York and Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame in Montreal, Quebec." - Anonymous Online Contributor
Unverified Answer
Are any individuals currently being enrolled into this research project?
"Correct. According to the information posted on clinicaltrials.gov, this medical study that was first published on November 12th 2012 is actively recruiting participants. 1724 patients need to be enrolled from 3 individual sites in order for the trial to be completed successfully." - Anonymous Online Contributor
Unverified Answer